Reviews Preparatory to Research
HIPAA provides a mechanism to access personally identifiable information for the purpose of "Reviews preparatory to research". This provision might be used to design a research study, to assess the feasibility of conducting a study, or to assemble a database of individuals who indicate a willingness to be considered for participation in future research studies.
Note that this mechanism does not permit the collection of data for conducting actual research or the removal of information from a covered entity. In addition, if the information is being provided by a covered entity, UB researchers who do not have staff privileges with that covered entity may not use this mechanism. If necessary, researchers in this situation should seek a waiver of authorization from the UB IRB. If the information is not being provided by a covered entity, or is being generated directly by a UB researcher, then UB researchers may use this mechanism as long as the use of the information adheres to the remaining "Reviews preparatory to research" requirements.
This mechanism consists of representations from the researcher (to the covered entity, if applicable), either in writing or orally, that:
Reviews Preparatory To Research Form This form does not require IRB review and may be presented directly to the covered entity (if applicable) from which you are seeking protected health information to conduct reviews preparatory to research.
Additional guidance from OCR on the reviews preparatory to research mechanism:
Q: Does the HIPAA Privacy Rule require documentation of Institutional Review Board (IRB) or Privacy Board approval of an alteration or waiver of individual authorization before a covered entity may use or disclose protected health information for any of the following provisions: (1) for preparatory research at 45 CFR 164.512(i)(1)(ii), (2) for research on the protected health information of decedents at 45 CFR 164.512(i)(1)(iii), or (3) a limited data set with a data use agreement as stipulated at 45 CFR 164.514(e)?
A: No. Documentation of IRB or Privacy Board approval of an alteration or waiver of individual authorization is only needed before a covered entity may use or disclose protected health information under 45 CFR 164.512(i)(1)(i) [waiver of authorization]. See the fact sheet and frequently asked questions about the research provisions on this web site for more information about Institutional Review and Privacy Boards.
Q: Can the preparatory research provision of the HIPAA Privacy Rule at 45 CFR 164.512(i)(1)(ii) be used to recruit individuals into a research study?
A: The preparatory research provision permits covered entities to use or disclose protected health information for purposes preparatory to research, such as to aid study recruitment. However, the provision at 45 CFR 164.512(i)(1)(ii) does not permit the researcher to remove protected health information from the covered entity's site. As such, a researcher who is an employee or a member of the covered entity's workforce could use protected health information to contact prospective research subjects. The preparatory research provision would allow such a researcher to identify prospective research participants for purposes of seeking their authorization to use or disclose protected health information for a research study. In addition, the Rule permits a covered entity to disclose protected health information to the individual who is the subject of the information. See 45 CFR 164.502(a)(1)(i). Therefore, covered health care providers and patients may continue to discuss the option of enrolling in a clinical trial without patient authorization, and without an Institutional Review Board (IRB) or Privacy Board waiver of the authorization. See the fact sheet and frequently asked questions about the research provisions on this web site for more information about Institutional Review and Privacy Boards.
However, a researcher who is not a part of the covered entity may not use the preparatory research provision to contact prospective research subjects. Rather, the outside researcher could obtain contact information through a partial waiver of individual authorization by an IRB or Privacy Board as permitted at 45 CFR164.512(i)(1)(i). The IRB or Privacy Board waiver of authorization permits the partial waiver of authorization for the purposes of allowing a researcher to obtain protected health information as necessary to recruit potential research subjects. For example, even if an IRB does not waive informed consent and individual authorization for the study itself, it may waive such authorization to permit the disclosure of protected health information as necessary for the researcher to be able to contact and recruit individuals into the study.
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